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一项关于比较伊达比星与柔红霉素(或其他蒽环类药物)作为急性髓系白血病诱导治疗的随机试验的系统协作综述。急性髓系白血病协作组。

A systematic collaborative overview of randomized trials comparing idarubicin with daunorubicin (or other anthracyclines) as induction therapy for acute myeloid leukaemia. AML Collaborative Group.

出版信息

Br J Haematol. 1998 Oct;103(1):100-9.

PMID:9792296
Abstract

A collaborative overview, using individual patient data, has been performed to compare idarubicin versus daunorubicin or other anthracyclines, when used with cytosine arabinoside as induction chemotherapy for newly diagnosed acute myeloid leukaemia. There were 1052 patients in five trials versus daunorubicin, 100 in one trial versus doxorubicin, and 745 in one trial versus zorubicin. In the trials of idarubicin versus daunorubicin, early induction failures were similar with the two treatments (20% idarubicin v 18% daunorubicin: P = 0.4), but after day 40 the later induction failures were fewer with idarubicin (17% v 29%: P < 0.0001). Therefore complete remission rates were higher with idarubicin (62% v 53%; P = 0.002). Among remitters, fewer of the patients allocated to idarubicin relapsed (P = 0.008) but slightly more died in remission, leading to a non-significant benefit (P = 0.07) in disease-free survival. Overall survival in these five trials was significantly better with idarubicin than with daunorubicin (13% v 9% alive at 5 years; P = 0.03). There was a trend (P = 0.006 for remission rate) for the benefit of idarubicin over daunorubicin to decrease with increasing age. There were no significant differences in outcome in the small trial comparing idarubicin versus doxorubicin, or in the large trial comparing idarubicin versus zorubicin. The induction regimens based on idarubicin achieved, in the particular circumstances of the trials reviewed here, better remission rates and better overall survival than those based on daunorubicin.

摘要

一项采用个体患者数据的综合分析已开展,旨在比较伊达比星与柔红霉素或其他蒽环类药物在与阿糖胞苷联合用于新诊断的急性髓系白血病诱导化疗时的疗效。五项试验中有1052例患者接受伊达比星与柔红霉素的对比,一项试验中有100例患者接受伊达比星与多柔比星的对比,一项试验中有745例患者接受伊达比星与佐柔比星的对比。在伊达比星与柔红霉素的试验中,两种治疗的早期诱导失败率相似(伊达比星为20%,柔红霉素为18%:P = 0.4),但在第40天后,伊达比星的后期诱导失败率更低(17%对29%:P < 0.0001)。因此,伊达比星的完全缓解率更高(62%对53%;P = 0.002)。在缓解者中,分配接受伊达比星治疗的患者复发较少(P = 0.008),但在缓解期死亡的患者略多,导致无病生存的获益不显著(P = 0.07)。在这五项试验中,伊达比星组的总生存期显著优于柔红霉素组(5年时存活者为13%对9%;P = 0.03)。随着年龄增加,伊达比星优于柔红霉素的获益有下降趋势(缓解率P = 0.006)。在比较伊达比星与多柔比星的小型试验以及比较伊达比星与佐柔比星的大型试验中,结局无显著差异。在此处回顾的试验的特定情况下,基于伊达比星的诱导方案比基于柔红霉素的方案实现了更好的缓解率和更好的总生存期。

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